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Reference Standards -Our Mission and Activities

PMRJ is registered as an organization that produces Japanese Pharmacopoeia (JP) Reference Standards (except those for antibiotics) by the Minister of Health, Labour and Welfare based on the Ministerial ordinance, and produces and distributes the official reference standards used for testing the quality of pharmaceuticals. PMRJ also produces and distributes the other official reference standards, the Tar-dye Reference Standards for TLC, and Food Additives Compendial Reference Standards as the registered organization. These reference standards are widely used for tests prescribed in the monographs of the official compendia such as JP, and play an important role in ensuring and improving the quality of pharmaceuticals in Japan by providing the basis for assurance of reliability and objectivity of the tests and assays.

The Osaka office of PMRJ, JP Reference Standards Laboratory (JPRS Lab) which has the responsibility of this mission, makes constant efforts to ensure the suitable quality and stable supply of the reference standards by contracting and practicing a quality management system for performing all work process flawlessly. Furthermore, through exchange with US and European pharmacopoeial reference standards producers , United States Pharmacopeial Convention (USPC) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) and by taking part in relevant international symposiums, JPRS Lab follows international trends on pharmacopeia and reference standard, and pursues improvement of technical level and reinforcement of producing system based on the international standards for the technical competency of reference material producers.

In addition to the above, JPRS Lab distributes United States Pharmacopeia (USP) Reference Standards to domestic users based on the distribution agreement with USPC. Since 2012, JPRS Lab has also started to distribute reference materials for pharmaceutical impurities produced by LGC Standards GmbH (Wesel, Germany) as well as European Pharmacopoeia (Ph.Eur.) Reference Standards, British Pharmacopoeia (BP) Reference Standards, and WHO ICRS as a distributor of the LGC Standards GmbH.

How We Work

How We Work

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